RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells. Combining chemotherapy with radiation therapy may kill more tumor cells.

PURPOSE: Phase I trial to study the effect on the body when combining irinotecan and cisplatin with radiation therapy in treating patients who have limited-stage small cell lung cancer that could not be completely removed during surgery.

Further study details as provided by Radiation Therapy Oncology Group:

Primary Outcome Measures:

Maximum tolerated dose of irinotecan in combination with cisplatin and thoracic radiotherapy (45 Gy BID or 70 Gy daily) by toxicity assessment (Common Toxicity Criteria version 3.0) during acute and late toxicity [ Time Frame: From the start of treatment until 90 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Rate of non-dose limiting toxicity [ Time Frame: From start of treatment to the end of follow-up ] [ Designated as safety issue: Yes ]

Group II: Patients undergo thoracic RT once daily, 5 days a week, for 7 weeks.

Concurrent chemotherapy: Patients receive irinotecan IV over 60-90 minutes on days 1 and 8 and cisplatin IV over 1 hour on day 1. Treatment repeats every 3 weeks for 1 course for group I and 2 courses for group II.

Post RT chemotherapy: Patients receive irinotecan and cisplatin as above for 3 courses for group I and 2 courses, beginning after RT is complete, for group II.

Sequential cohorts of 6 patients per group receive escalating doses of irinotecan until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose-limiting toxicity.

Patients are followed every 3 months for 1 year and then 6 months for 4 years.

PROJECTED ACCRUAL: A total of 12-36 patients (6-18 per group) will be accrued for this study within 18 months.

Eligibility

Ages Eligible for Study:

18 Years and older

Genders Eligible for Study:

Both

Accepts Healthy Volunteers:

No

Criteria

DISEASE CHARACTERISTICS:

Histologically or cytologically confirmed small cell lung cancer by one of two methods:

Fine needle aspiration biopsy

Two positive sputa

Must have limited disease as defined by all of the following:

Stage I-IIIB

Confined to 1 hemithorax

No T4 tumor based on malignant pleural or pericardial effusion

Patients with pleural effusion too small to tap under CT guidance and not evident on chest x-ray are allowed

No N3 disease based on contralateral hilar or contralateral supraclavicular involvement

Measurable or evaluable disease

Tumor must be able to be encompassed by specified radiotherapy fields without unacceptable risk of serious pulmonary compromise

No complete tumor resection

No pericardial effusion (regardless of cytology)

PATIENT CHARACTERISTICS:

Age

18 and over

Performance status

Zubrod 0-1

Life expectancy

Not specified

Hematopoietic

Absolute granulocyte count at least 1,500/mm^3

Platelet count at least 120,000/mm^3

Hepatic

Bilirubin no greater than 1.5 mg/dL

No known Gilbert's disease

Renal

Creatinine no greater than 1.5 mg/dL

Cardiovascular

No myocardial infarction within the past 6 months

No symptomatic heart disease

Pulmonary

Forced expiratory volume (FEV)_1 at least 1.0 L/sec

No uncontrolled bronchospasms

No uncompensated chronic obstructive pulmonary disease

Other

Not pregnant or nursing

Negative pregnancy test

Fertile patients must use effective contraception

No pre-existing peripheral neuropathy grade 2 or greater

No other malignancy within the past 2 years except curatively treated basal or squamous cell skin cancer or carcinoma in situ of the bladder or cervix

No other concurrent serious medical illness

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior biologic therapy

Chemotherapy

No prior chemotherapy

Endocrine therapy

Not specified

Radiotherapy

No prior radiotherapy

No concurrent intensity-modulated radiotherapy

Surgery

See Disease Characteristics

Other

At least 7 days since prior enzyme-inducing anti-convulsant drugs (EIACDs) (e.g., phenytoin, carbamazepine, or phenobarbital) if used on a regular basis for more than 2 weeks

Less than 2 weeks of regular use of EIACDs does not require a 7-day wash-out period

At least 14 days since prior Hypericum perforatum (St. John's wort)

No concurrent EIACDs

No concurrent amifostine during chemoradiotherapy

Concurrent gabapentin or other non-EIACDs allowed

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00059761